Diabetic Foot, Postoperative Wound Healing
Conditions
Keywords
diabetic foot, wound healing, postoperative wound, pilot study, oxygen-enriched oil-based dressing
Brief summary
This study is a prospective randomized controlled pilot study evaluating the efficacy and safety of an OEOd-based wound dressing compared with standard wound care in patients with post-surgical diabetic foot ulcers. Participants were randomly assigned at enrollment to receive either the OEOd-based dressing or standard therapy. The primary outcome was complete ulcer healing at 16 weeks. Secondary outcomes included new infections, need for additional surgical debridement, re-hospitalization, and time to healing. The study was designed to provide preliminary estimates of treatment effect and feasibility to inform future larger randomized trials.
Detailed description
This study was designed as a prospective randomized controlled pilot study to evaluate the efficacy and safety of an OEOd-based wound dressing compared with standard wound care in patients with post-surgical diabetic foot ulcers. Adult patients with diabetes mellitus presenting with a post-surgical foot ulcer were prospectively enrolled and randomly assigned at the time of enrollment to receive either the OEOd-based wound dressing or standard therapy, according to a simple random allocation procedure. All patients received standard multidisciplinary diabetic foot care, including surgical management when indicated, infection control, off-loading, and metabolic optimization. The investigational intervention consisted of a topical OEOd-based wound dressing applied according to routine clinical practice. The primary endpoint of the study was complete ulcer healing at 16 weeks, defined as full epithelialization of the target lesion without drainage. Secondary endpoints included the occurrence of new infections, the need for additional surgical debridement, re-hospitalization during follow-up, and time to healing, which was evaluated as an exploratory outcome. Given the pilot nature of the study, no formal a priori sample size calculation was performed. The trial was intended to provide preliminary estimates of treatment effect and feasibility to inform the design of future larger randomized controlled studies.
Interventions
DEVICEOEOd-based wound dressing
Topical application of an OEOd-based wound dressing to post-surgical diabetic foot ulcers according to routine clinical practice, in addition to standard multidisciplinary diabetic foot care.
Conventional wound management for post-surgical diabetic foot ulcers according to institutional standard clinical practice.
Sponsors
Ospedale San Donato
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Participants were randomly assigned in parallel to one of two study groups: an intervention group receiving an OEOd-based wound dressing and a control group receiving standard wound care. Each participant was allocated to a single treatment group for the duration of the study.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adults (≥18 years) with diabetes mellitus * Presence of a post-surgical diabetic foot ulcer * Eligibility for topical wound treatment * Ability to provide written informed consent
Exclusion criteria
* Active malignancy * Severe systemic infection or sepsis * Known hypersensitivity to components of the wound dressing * Inability to comply with study procedures or follow-up * Participation in another interventional clinical study during the same period
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Complete ulcer healing | 16 weeks | number of ulcers completely healed at 16 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| new infections | 16 weeks | number of patients with new clinically diagnosed wound infections during follow-up. |
| Additional surgical debridement | 16 weeks | number of patients needing additional surgical debridement of the target ulcer during follow-up. |
| re-hospitalization | 16 weeks | number of Hospital admission related to the target ulcer during the follow-up period. |
| time to healing | 16 weeks | Time from enrollment to complete ulcer healing, evaluated as an exploratory outcome. |
Countries
Italy
Contacts
PRINCIPAL_INVESTIGATORAlessia Scatena, MD
Diabetology and Metabolism Unit, San Donato Hospital Arezzo, Local Health Authority South-East Tuscany, iTaly
Outcome results
None listed